eflornithine has been researched along with Cells, Neoplasm Circulating in 1 studies
Eflornithine: An inhibitor of ORNITHINE DECARBOXYLASE, the rate limiting enzyme of the polyamine biosynthetic pathway.
eflornithine : A fluoroamino acid that is ornithine substituted by a difluoromethyl group at position 2.
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 0 (0.00) | 29.6817 |
| 2010's | 0 (0.00) | 24.3611 |
| 2020's | 1 (100.00) | 2.80 |
| Authors | Studies |
|---|---|
| Batth, IS | 1 |
| Dao, L | 1 |
| Satelli, A | 1 |
| Mitra, A | 1 |
| Yi, S | 1 |
| Noh, H | 1 |
| Li, H | 1 |
| Brownlee, Z | 1 |
| Zhou, S | 1 |
| Bond, J | 1 |
| Wang, J | 1 |
| Gill, J | 1 |
| Sholler, GS | 1 |
| Li, S | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Phase II Preventative Trial of DFMO (Eflornithine HCl) as a Single Agent in Patients With High Risk Neuroblastoma in Remission[NCT02395666] | Phase 2 | 140 participants (Actual) | Interventional | 2015-03-05 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
"Pharmacokinetic assay AUC(0-6 hr)/D~Samples drawn at 5 timepoints: (0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose) on two different days" (NCT02395666)
Timeframe: 0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose on two different days
| Intervention | hr*ng/mL (Mean) |
|---|---|
| Study Subjects Consented to PK Collection | 47024 |
To continue to determine the safety and tolerability of DFMO as a single agent and in pediatric and young adult patients with high risk neuroblastoma that is in remission. (NCT02395666)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|---|
| DFMO Twice Daily | 57 |
To evaluate the preventative activity of DFMO as a single agent in patients that are in remission based on: Event free survival (EFS) (NCT02395666)
Timeframe: 2 Years
| Intervention | percentage of subjects without an event (Mean) |
|---|---|
| Stratum 1 | 84 |
| Stratum 2 | 51 |
"Pharmacokinetic assay Cmax/D~Samples drawn at 5 timepoints: (0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose) on two different days." (NCT02395666)
Timeframe: Samples drawn at 5 timepoints: (0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose) on two different days
| Intervention | ng/mL (Mean) |
|---|---|
| Study Subjects Consented to PK Collection | 11958 |
To evaluate the preventative activity of DFMO as a single agent in patients with neuroblastoma who are in remission based on: Overall Survival (OS) (NCT02395666)
Timeframe: 2 Years
| Intervention | percentage of subjects without an event (Mean) |
|---|---|
| Stratum 1 | 97 |
| Stratum 2 | 84 |
"Tests (p-value) of the association of survival with ODC1 single nucleotide polymorphism rs2302616 genotype.~Blood: microRNA analysis as predictor of DFMO effect, ornithine decarboxylase (ODC) single nucleotide polymorphism (SNP) analysis in DNA isolated from nucleated cells" (NCT02395666)
Timeframe: 2 years
| Intervention | p-value (Number) |
|---|---|
| GG, GT, TT | 0.96 |
| GG or GT, TT | 0.58 |
| GG, GT or TT | 0.67 |
"Pharmacokinetic assay- tmax, hr~Samples drawn at 5 timepoints: (0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose) on two different days" (NCT02395666)
Timeframe: 0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose on two different days
| Intervention | hours (Mean) |
|---|---|
| Study Subjects Consented to PK Collection | 3.3 |
1 other study available for eflornithine and Cells, Neoplasm Circulating
| Article | Year |
|---|---|
Cell surface vimentin-positive circulating tumor cell-based relapse prediction in a long-term longitudinal study of postremission neuroblastoma patients.
Topics: Biomarkers, Tumor; Cell Line, Tumor; Clinical Trials, Phase II as Topic; Early Detection of Cancer; | 2020 |